[Osteopathy for chronic pain after breast cancer surgery: A monocentric randomised study]. / Étude randomisée monocentrique évaluant l'efficacité de l'ostéopathie dans la prise en charge des douleurs chroniques après chirurgie mammaire en oncologie.

Twenty-five to 65% of patients suffer from chronic pain after breast cancer. The treatment combines analgesic drugs and psychophysical techniques. HYPOTHESIS: Osteopathy improves the control of pain and the quality of life of patients. METHODS: This randomized prospective single center study allocated patients to the initiation of a standard analgesic treatment exclusively (arm A) or associated to osteopathy (arm B) between from 1 to 12months after surgery. MAIN OBJECTIVE: Intensity of pain (VAS at three months [j90]). SECONDARY OBJECTIVES: Pain (VAS) at 6 and 12 months, analgesic consumption, anxiety/depression (HADS), and Quality of life (QLQ-C30). Eighty patients were planned to observe a 2-point difference in VAS (5% bilateral alpha, 90% power). RESULTS: Twenty-eight patients (A: 14; B: 14, median age 50 years) were included from April 2011 to February 2014; the study was stopped due to a too slow recruitment. No difference in the VAS pain score between arms was observed at j90 (P=0.258), nor at 6 and 12 months. At j90, the HADS depression score was reduced in arm B (P=0.049). Improvement in the overall score of quality of life (P=0.015), and reduced pain sub-score (P=0.021) were observed at j90 in arm B. DISCUSSION: Patients are strongly seeking complementary therapies. Few studies exist. Our study has encountered major recruitment difficulties therefore limiting the interpretation of the results. Despite the absence of difference in the main objective, some other scores (QOL, depression) are noteworthy in favor of osteopathy. Further multicentric studies are needed.

Decrease in factor V activity in patients treated with azathioprine or 6-mercaptopurine.

BACKGROUND AND OBJECTIVE: A decrease in factor V activity has been reported in some patients treated with azathioprine or 6-mercaptopurine. This may lead to unnecessary treatment discontinuation in otherwise asymptomatic patients. Our aim was to review spontaneously reported cases of decreased factor V activity associated with both drugs and to identify the possible impact on patient care. METHODS: Cases of decrease in prothrombin (PT) or factor V activity involving purine analogs were extracted from the French pharmacovigilance database. Reports with evidence of disseminated intravascular coagulation, signs of acute hepatocellular failure, liver cirrhosis or concomitant vitamin K antagonist treatment were excluded. RESULTS: Twenty-four cases (azathioprine: 13 and 6-mercaptopurine: 11) were retained. Therapeutic indications were inflammatory bowel diseases in 11 patients, acute leukemia in eight, and other autoimmune diseases in five. PT activity before treatment was normal in all nine tested patients. The decrease in PT or factor V activity occurs after a median of 10 weeks of treatment and all patients were asymptomatic. The median PT and factor V activities values were 51.5% and 36.4%, respectively. Other coagulation factors were inconsistently decreased. Full recovery was observed within 3-60 days following purine analogs discontinuation. In four patients, drug rechallenge was associated with recurrence of the coagulation disorders. CONCLUSIONS: Although the mechanism remains unknown, this series that includes cases with positive drug reintroduction strongly suggests the causative role of these drugs. As all patients remained asymptomatic, treatment discontinuation should be carefully considered in patients who clearly benefits from this treatment.

Piribedil-induced sleep attacks in patients without Parkinson disease: a case series.

BACKGROUND: Sleep attacks were initially described in 1999 in patients with Parkinson disease (PD) treated by dopamine agonists (DAs). Because the respective role of DAs or PD-induced excessive daytime sleepiness is still unclear, reports of sleep attacks in non-PD patients treated with DA would support the specific role of these drugs. Piribedil, a nonergot dopamine D2/D3 agonist with alpha(2)-noradrenergic properties, is indicated in the treatment of PD as well as in patients with circulatory disorders. After a spontaneous report of sleep attack associated with piribedil use in a non-PD patient, we reviewed other cases from the French pharmacovigilance database. MATERIALS AND METHODS: Cases of piribedil associated with sleep attacks recorded between 1988 and December 2008 were identified in the French Pharmacovigilance database. Cases were retained for analysis only if patients were treated for conditions other than PD. RESULTS: Overall, a total of 35 cases of piribedil-induced sleep disorders were retrieved, and 7 cases suggestive of sleep attacks were retained for analysis. The mean time to onset after starting piribedil was 2.5 days. Piribedil was the only suspected drug in all but 1 patient. Complete recovery was noticed after piribedil discontinuation in all patients, and recurrence of symptoms was observed after piribedil reintroduction in 1 patient. CONCLUSIONS: Our series suggests that piribedil may be associated with sleep attack disorders independently of the treated disease and supports the prominent role of DAs in sleep disorders.